FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...

George Tidmarsh, a Stanford University physician who founded Horizon Pharma and later ran La Jolla Pharma, was named head of ...

“Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development — ...

FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...

The new CNPV program will allow drug developers to participate in a novel FDA priority program that significantly shortens the review time for a final drug application from approximately 10-12 ...

The founder and former CEO of several pharmaceutical companies, Tidmarsh was tapped by FDA Commissioner Marty Makary, MD, MPH ...

FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and unnecessary delays in the regulatory process.